What are FDA‑approved indications and exact dosing tables for human ivermectin products?
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Executive summary
The U.S. FDA has approved ivermectin for specific human parasitic diseases and a topical formulation for rosacea; the commonly cited oral doses are single-dose 150 μg/kg for onchocerciasis and approximately 200 μg/kg (170–200 μg/kg in trials) for intestinal strongyloidiasis, while topical ivermectin is approved for facial rosacea at labeled topical strengths and schedules [1] [2] [3]. Ivermectin is not FDA‑approved for COVID‑19 or other viral infections, and veterinary formulations contain much higher concentrations that have caused human toxicities when misused [4] [5] [6].
1. What the FDA has approved: indications and formulation categories
Official human approvals center on systemic antiparasitic therapy—oral ivermectin tablets for intestinal strongyloidiasis and for onchocerciasis (“river blindness”)—and a topical ivermectin product for rosacea; major clinical and toxicology reviews reiterate these as the only current human FDA‑approved disease indications and formulations [2] [1] [3].
2. Exact systemic dosing for parasitic diseases (oral tablets)
For intestinal (nondisseminated) strongyloidiasis, pivotal trials and the ivermectin tablet prescribing information use a single oral dose designed to deliver approximately 200 micrograms per kilogram of body weight (range in studies commonly cited as 170–200 μg/kg as a single dose) with clinical cure rates driven by that single‑dose strategy [1]. For onchocerciasis, the standard recommended dose used in studies and practice is a single 150 μg/kg oral dose, repeated at intervals as clinically indicated for control of microfilariae [7] [2]. Public sources also report doses used in mass‑drug‑administration programs—such as annual 400 μg/kg regimens for lymphatic filariasis in some programs—but those uses and schedules vary by program and geography and are not the primary FDA labeling cited for human tablet approvals in the U.S. context [7].
3. Topical dosing for dermatologic use
Topical ivermectin products are FDA‑authorized for rosacea; the labeled topical formulations are applied to the face as specified in the product instructions (clinical references list it as an approved therapy for papulopustular rosacea), and clinicians prescribe according to the approved cream/solution strength and application frequency in the prescribing information rather than by μg/kg systemic equivalents [3].
4. What is not approved and dose‑related risks
Regulatory and public health agencies explicitly state ivermectin is not authorized or approved for prevention or treatment of COVID‑19; FDA and CDC warnings emphasize that doses being taken by some individuals for COVID‑19 often exceed the ranges used in approved human indications and can lead to serious adverse events, with poison control centers reporting sharp increases in exposures linked to inappropriate human use of veterinary products [4] [5] [8] [9] [10]. Veterinary pour‑on and concentrate products are formulated at much higher concentrations (examples: cattle pour‑on labeled at about 500 μg/kg application rates or dosing instructions of 1 mL per 22 lb) and include inactive ingredients not evaluated in humans; misuse of those products has produced toxicities [6] [11] [2].
5. Higher‑dose research and off‑label context (what clinicians and trials are testing)
Controlled clinical research has explored higher systemic regimens for repurposing questions—e.g., investigational arms testing 600 μg/kg daily for six days in COVID‑19 trials—but those are investigational doses within trials and do not constitute FDA approval for those indications; medical societies and toxicology groups urge that off‑label high‑dose use should be limited to research settings because safety and efficacy have not been established [12] [2].
Conclusion and reporting limits
The authoritative, FDA‑linked prescribing information and clinical toxicology sources converge on oral ivermectin dosing of ~200 μg/kg single dose for strongyloidiasis and 150 μg/kg single dose for onchocerciasis, plus topical labeled regimens for rosacea; anything above those ranges for unapproved indications should be considered experimental and potentially dangerous, especially when veterinary products are involved [1] [2] [3] [6]. This account relies on the cited prescribing information, public health advisories, and product labels; if additional FDA label extracts or updated product inserts are required, those specific documents were not supplied in full here and would need to be consulted for exact wording and administration instructions [1] [3].